21 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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MODIFICATION TO: HL168W TOUCH SCREEN
FDA 510(k)
FDA Class 2
·Cardiovascular
Diamond D
FDA UDI
Keystone Industries·H66810130331·Denture Acryic HC Chroma Ess pwd
Disposable frosted scleral depressor
FDA UDI
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.·08717872030579·Disposable frosted scleral depressor. (accessor...
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588741·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588727·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588703·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588710·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588758·
MAGNIVISION
FDA UDI
FGX INTERNATIONAL INC.·00193033588734·
Navagio
FDA UDI
Kalitec Direct LLC·B073DRK0100330·Assembly, Navagio Fixed Draw Rod, Large Knob
LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SCAPHIX, STAPLE, FIXATION, BONE
FDA 510(k)
FDA Class 2
·Orthopedic
SCHILLER
FDA Adverse Event
Malfunction
·SCHILLER AG·Product code MHX·November 2, 2006
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·March 1, 2013
ACCU-CHEK RAPID D LINK
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code FPA·March 4, 2011
NEONATAL & PEDIATRIC ENDOTRACHEAL TUBE HOLDER
FDA Adverse Event
Injury
·SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.·Product code CBH·February 29, 2008
COBRA VISION
FDA Adverse Event
Malfunction
·RICHARD WOLF GMBH·Product code FGB·August 23, 2019
bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025
Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
FDA Enforcement
Class II
·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014
Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018